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Purdue Pharma has requested permission from the U.S. Bankruptcy Court for the Southern District of New York to develop a new product to reverse opioid overdoses. A hearing before the court has been set for Feb. 21. Read More
The agency is “not aware of any medicines or supplements available without prescription that will prevent or assist with recovery from a novel coronavirus infection,” TGA said. Read More
Amgen is calling for a jury trial for Hospira in the U.S. District Court for the District of Delaware, alleging that the Pfizer subsidiary’s proposed Neulasta (pegfilgrastim) biosimilar infringed on its patents for the anti-infection drug. Read More
HHS Secretary Alex Azar defended the administration’s proposed fiscal 2021 budget before the Senate Finance Committee yesterday and noted that the budget “supports quick congressional action” to lower the cost of prescription drugs. Read More
Mallinckrodt is facing another class-action suit over the price of its H.P. Acthar Gel (repository corticotropin), this time from the city of Marietta, Georgia. Read More
CDER has launched a Controlled Substances Program (CSP) to help develop new policies and programs to encourage “appropriate access” to scheduled drugs. Read More
Former FDA Commissioner Scott Gottlieb warned a Senate committee yesterday of the potential for “unprecedented supply chain disruptions” as the COVID-19 outbreak threatens China’s production of starting materials. Read More